Devices

Device Recall Tumor Localization (Tumor LOC) software application

Model / Serial
Lot Numbers: 7001-7354 for BB; and 8222, 8270, 8709, 8838, 8841, 8862, 8986, 9014, 9019, 9127, 9166, 10331, 10348, 10364, 10402, 10705, 10827, 11002, 11047, 11055, 11096, 11362, 11588, and 11597, for EBW.
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Jordan, Libyan Arab Jamahiriya, Lithuania, Malaysia, Netherlands Antilles, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Tahiti, Taiwan, Thailand, United Kingdom and Venezuela.
Product Description
TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc). || The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Manufacturer
Philips Medical Systems (Cleveland) Inc
1 Event
- Recall of Device Recall Tumor Localization (Tumor LOC) software application

Manufacturer

Philips Medical Systems (Cleveland) Inc

Manufacturer Address
Philips Medical Systems (Cleveland) Inc, 595 Miner Road, Cleveland OH 44143-2131
Source
USFDA

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